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510(k) Data Aggregation

    K Number
    K232978
    Device Name
    DX. Bond V Dental Bonding Adhesive
    Manufacturer
    Sino-Dentex Co., Ltd.
    Date Cleared
    2023-09-22

    (366 days)

    Product Code
    KLE
    Regulation Number
    872.3200
    Why did this record match?
    Applicant Name (Manufacturer) :

    Sino-Dentex Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1.Bonding for all Classes of direct composite restoration 2.Bonding for indirect procedures involving metal, porcelain, and composite
    Device Description
    DX. Bond V Dental Bonding Adhesive is a multi-purpose dental bonding adhesive for all classes of direct composite restoration as well as for indirect procedures involving metal, porcelain and composite. DX. Bond V is also used for amalgam, self- cure composite and orthodontic brackets bonding. DX. Bond V consists of methylmethacrylates and solvent. After applied to bonding area with thin layer, methylmethacrylates are initiated by free radical with blue light and then polymerized to form cross-linking polymer network resulting in solid and strong bonding membrane. The adhesive is dropped onto a mixing pad before application.
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